NCT05905419

Neuroimaging of Opioid Phase (OPAL)

Neurobiological Consequences of Long-Term Opioid Therapy in the Brain and Spinal Cord

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare activity in the brains of female adults with chronic pain and/or opioid use, and healthy female adults that may help to develop new and targeted treatments for adults with chronic pain and alternatives to opioid therapy.

Detailed description

The objective of the study is to determine differences in neurophysiology and behavior during different phases of opioid use in patients. Study activities will include neuroimaging (MRI and fMRI), behavioral tasks, sensory testing, blood draws, and questionnaires. The neuroimaging data will be analyzed using specialized software; data from questionnaires, sensory testing, and behavioral task performance will be analyzed using standard statistical software. Risks and safety concerns include standard, minimal risks associated with MRI scans, sensory testing, blood draws, and confidentiality.

Conditions

• Chronic Pain
• Opioid Use

Interventions

Type	Name	Description
OTHER	Opioid Phase	Opioid-taking patients are assigned to take their prescribed opioid medication before ("peak" opioid phase) during 1 scan and after ("trough" opioid phase) during the other MRI scan

Timeline

• Start date: 2023-06-01
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2023-06-15
• Last updated: 2025-09-04

Locations

1 site across 1 country: United States